Prostate Cancer Clinical Trial

A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

Summary

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed prostatic adenocarcinoma.
History of metastatic disease.
Chemically or surgically castrate.
Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.
Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV)-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
Subject must have adequate heart, liver, bone marrow and kidney function (e.g. estimated glomerular filtration rate [eGFR] ≥ 50 mL/min, aspartate aminotransferase [AST]/alanine aminotransferase [ALT] ≤ 3 x upper limit of normal [ULN], hemoglobin [Hgb] ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment), platelets ≥ 100,000 / mm^3 (without platelet transfusion within 7 days from screening assessment), absolute neutrophil count [ANC] ≥ 1500 / mm^3).

Exclusion Criteria:

Subject has been diagnosed with or treated for another malignancy within the past 2 years whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
History of neuroendocrine differentiation in the subject's disease.
Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.
Subject has clinically significant CNS pathology.
Subject requires chronic immunosuppressive therapy.
Subject has a history of major cardiac abnormalities.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT04740034

Recruitment Status:

Recruiting

Sponsor:

Amgen

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 7 Locations for this study

See Locations Near You

UCSF
San Francisco California, 94158, United States
Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Tulane Cancer Center
New Orleans Louisiana, 70112, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10128, United States
Thomas Jefferson University - Sidney Kimmel Cancer Center
Philadelphia Pennsylvania, 19107, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT04740034

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.